Body Composition & REE Responses to Bariatric Surgery

NCT ID: NCT00682058

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2018-06-30

Brief Summary

The aim of this study is to measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and fat-free mass (FFM) (bone mineral density, skeletal muscle, and specific organs) at 60 months (T60) and 84 months (T84) post-surgery, and to compare compartment sizes with stable weight controls.

Detailed Description

Consenting, eligible patients previously enrolled in the ancillary study, "Longitudinal Assessment of Bariatric Surgery" (LABS), from Weill Cornell and the University of Pittsburgh will undergo the following measures: total body water by deuterium dilution (fat and fat-free mass (FFM)), extracellular water by sodium bromide tracer, body density by the BodPod, whole-body magnetic resonance imaging (MRI) (adipose tissue and its distribution; skeletal muscle mass; mass of liver, kidneys, heart, and brain), dual energy-X-ray absorptiometry (femur bone mineral density (BMD), total body fat, fat-free mass, and bone mineral content), and resting energy expenditure (REE). MRI will describe body composition changes at the tissue/organ level and adipose tissue distribution allowing us to address questions of biological and clinical importance including the body composition changes' influences on REE. The specific aims are to: 1) measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and FFM (including bone mineral density, skeletal muscle, and specific organs) at T60 and T84 months following surgery, and also to compare compartment sizes with those seen in stable weight controls; 2) measure the amount of change in REE at T60 and T84 compared to T0, following weight loss induced by bariatric surgery and to determine its relation to changes in body composition compartments, and its duration over the follow-up period. Secondary research questions relate to changes in cardiac structure and function, physical activity associations with skeletal muscle changes, and adipose tissue depot changes as predictors of cardiometabolic parameters (glucose metabolism and serum lipid composition). Subjects will be women and men (n=100) equally distributed between the New York and Pittsburgh sites.

Conditions

Weight Loss; Weight Change

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

LABS patients

Bariatric surgery patients with 35\>BMI kg/m2\<60 prior to surgery will undergo follow-up post-bariatric surgery.

Follow-up post-bariatric surgery

Intervention Type: OTHER

Follow-up of those subjects who had bariatric surgery (as part of the parent LABS trial) immediately following the collection of baseline measures (body composition) in this study. Follow-up body composition measures will be acquired at 60 months and 84 months post-baseline measures (post-surgery).

Interventions

Follow-up post-bariatric surgery

Follow-up of those subjects who had bariatric surgery (as part of the parent LABS trial) immediately following the collection of baseline measures (body composition) in this study. Follow-up body composition measures will be acquired at 60 months and 84 months post-baseline measures (post-surgery).

Intervention Type: OTHER

Other Intervention Names

Observational at this time with no intervention

Eligibility Criteria

Inclusion Criteria

• Had to have been enrolled in the ancillary study prior to having bariatric surgery
• Are able to come to the laboratory for testing.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Dympna Gallagher

Associate Professor of Nutritional Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Delany, PhD

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

Ashby-Thompson M, Heshka S, Rizkalla B, Zurlo R, Lemos T, Janumala I, Goodpaster B, DeLany J, Courcoulas A, Strain G, Pomp A, Kang P, Lin S, Thornton J, Gallagher D. Validity of dual-energy x-ray absorptiometry for estimation of visceral adipose tissue and visceral adipose tissue change after surgery-induced weight loss in women with severe obesity. Obesity (Silver Spring). 2022 May;30(5):1057-1065. doi: 10.1002/oby.23415. Epub 2022 Apr 6.

Reference Type: DERIVED

PMID: 35384351 (View on PubMed)

Other Identifiers

R01DK072507

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAO1655

Identifier Type: -

Identifier Source: org_study_id